EMA OKs Booster Doses of Pfizer’s/BioNTech’s, Moderna’s COVID-19 Vaccines

The European Medicines Agency (EMA) has authorized booster doses of Pfizer’s/BioNTech’s and Moderna’s COVID-19 vaccines, Comirnaty and Spikevax, respectively.

The EMA’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on the administration of Pfizer’s/BioNTech’s COVID-19 vaccine, Comirnaty, as a booster dose at least six months after the second dose in individuals 18 years of age and older.

The European Commission (EC) will review the CHMP recommendation and is expected to make a final decision on a variation to the conditional marketing authorization in the near future (as reported on October 4, 2021). If the EC grants the variation regarding a booster dose, the decision will be immediately applicable to all 27 EU member states.

Pfizer and BioNTech continue to supply the COVID-19 vaccine, including sufficient volume for boosters, under their existing supply agreement with the EC. The companies say they do not expect the introduction of booster doses in the US and the EU (if authorized) to impact the existing supply agreements in place with governments and international health organizations

Last month (September 2021), the US authorized a third (booster dose) of Pfizer’s/BioTech’s vaccine in certain populations: (1) people 65 years and older and residents in long-term care settings; (2) people aged 50–64 years with underlying medical conditions; (3) people aged 18–49 years with underlying medical conditions, based on their individual benefits and risks; and (4) people aged 18-64 years who are at increased risk for COVID-19 exposure and transmission because of occupational or institutional setting, based on their individual benefits and risks.

The EMA has also authorized a third dose of the Moderna’s COVID-19 vaccine, Spikevax, given at least 28 days after the second dose to severely immunocompromised individuals 12 years of age or older.

Source: European Medicines AgencyModerna, and BioNTech